Sterile packaging of medical devices with enhanced tamper evident, transportation, functional and disposal features

ABSTRACT

A syringe assembly (or other medical device) includes a single syringe entirely enclosed and sealed within a shrink-wrap film package, with one of the syringe or package formed so as to facilitate removal of at least a portion of the shrink wrap package. A related method of packaging, using and disposing of a syringe includes enclosing and sealing a single syringe assembly within a shrink wrap package, the syringe assembly including a barrel, a plunger slidable within the barrel, a thumb press at one end of the plunger projecting rearwardly of the barrel, and a needle at an opposite end of the barrel; 
     removing a portion of the shrink wrap package enclosing the needle; using the syringe in a liquid injection or removal mode while leaving a remaining portion of the shrink wrap package on the syringe assembly; and disposing the used syringe assembly with the remaining portion of the shrink wrap package in place on the syringe. 
     Because of the closely applied packaging film reduced volume and weight of secondary packaging and consequent, reduced sterilization, transportation, and disposal costs. 
     Use of distinctive shrink-wrap color, structure or other characteristic prevents simple deceptive duplication. 
     Applicability to other devices which require internal sterility, but do not require external sterility in use.

BACKGROUND

This invention relates to sterile packaging and disposal of medical devices and particularly to the packaging and disposal of individual syringes, needles, cannulae and the like.

Large numbers of disposal medical devices are manufactured, sterilized, transported, used and disposed of worldwide. Most are used one time only and then discarded. The production, sterilization, packaging, transportation and disposal criteria for syringes create significant resource consumption for manufacturers, and improper disposal can have a large negative impact on the environment. Further, serious diseases can be spread by the re use of single use disposable syringes which are improperly reused then repackaged without sterilization. In some developing countries many or even most syringes are re-used in this way with disastrous consequences.

For decades, the design, manufacture, and disposal of plastic hypodermic syringes has remained relatively unchanged. It is estimated that at least 20 billion are used and disposed of annually. In recent years many syringe designs have emerged with specific features to prevent reuse, to allow pre-filling with medication, and to prevent needlestick injuries. However, there has been little change in the packaging, sterilization, transportation and disposal methodologies. Syringes are used for many functions, e.g., vaccination, reconstitution, therapeutic injections and fluid transfer in many sites, e.g., hospitals, clinics, rural and in all countries. These different uses allow development of more use-specific, cost effective means of packaging, sterilization, transportation and disposal. As syringes are almost invariably required to be internally sterile for use, the design and integrity of the packaging is essential. This same principle applies to many medical devices and hence this packaging is applicable to a variety of medical devices in addition to syringes.

Some syringes are used in the sterile field environment of the operating room. In this situation it is necessary that the external surfaces of the syringe and needle as well as the internal structure of the syringe be sterile. On the other hand, in situations such as vaccination programs, while it is necessary for the needle and the interior of the syringe to be sterile, the external surfaces of the syringe need not be sterile during syringe filling or during injection. In such vaccination programs, ease of transportation to remote vaccination sites and safe storage under difficult environmental situations may be very important.

Recently, attention has been paid to the social and environmental impact of the disposal of contaminated syringes, needles and the associated packaging after use. In the developed world, the priority has been protection of the healthcare worker from the contaminated syringe and the inherent possibility of accidental needlestick injury. In the developing world, a major priority has been the safe and environmentally friendly disposal of both the used syringe and its packaging. To date, however, little attention has been paid to packaging and disposal in developed countries. In both developed and developing countries, an improved method of transporting and disposing of syringes and related packaging materials would have economic and environmental advantages.

Traditionally, individual syringes and needles have been packaged in form, fill and seal blister packages or pouches from which the syringe can be removed manually or ejected onto a sterile field in a manner which allows the external surfaces of the syringe to be maintained sterile. This is absolutely necessary if the syringe is to be used in a sterile operating room field. However most syringes are not used in circumstances where it is necessary to maintain the external sterility of the syringe. In addition, the traditional form fill and seal package is deliberately designed to allow easy opening by peeling apart the two webs from which the package is made. These webs are usually heat sealed and after the syringe is removed it is not difficult to re use the package and obtain a second heat seal of the package as was done in the manufacturing plant. Many inexpensive easily obtained home food packaging machines can effect such a seal and obtain a result not easily distinguishable from the factory seal. This fact then allows inappropriate repackaging of used, washed but not sterilized syringes simply and cheaply. The packaging taught herein is effectively destroyed when opened which acts as a tamper evident control on repackaging intended to replicate the original sterile syringe.

While traditional individual primary packaging, form fill and seal or similar pouches, are designed to ensure both external and internal sterility, the current configurations are not usually designed to minimize the volume or weight. of the packaging. The syringe in its primary packaging requires secondary packaging, i.e., boxes and cartons for transportation. Sterilization of syringes is carried out with the individually packaged syringes inside the secondary packaging, including both storage boxes and transportation cartons. Therefore, any decrease in individual syringe packaging will be reflected in the secondary packaging storage boxes and transportation cartons being of smaller size also. This will reduce the total volume of syringes inside primary and secondary packaging presented to the sterilization facility. It is expected that this will decrease time for processing and therefore reduce the cost of sterilization.

During syringe use, it is often necessary to measure accurately the volume of solution within the syringe. At other times, however, such as flushing an intravenous line, the precise volume of fluid used is not usually measured. Similarly, if the entire contents of a vial of fluid is transferred to another vial, it may not be necessary or common practice to read the index markings on the syringe barrel. This obviously makes visualization of the index markings of little importance. This may be relevant if, as is proposed in one embodiment of this application, the packaging may be intended to remain on the syringe during use or if the syringe is pre filled with medication.

Therefore, there appears to be an opportunity for improved possibly, use-specific packaging for single use disposable medical devices such as syringes and needles. The described but non-limiting embodiments described herein address many of the issues related to the transport, use, and disposal of sterile disposable medical devices. The proposed packaging is intended to be used primarily for syringes in situations where the absolute sterility of the external surface of the syringe is not necessary but internal sterilization is. Some of the described packaging may remain on the syringe during use (the same packaging could also be used for syringes which require sterility both internally and externally). The volume of packaging requiring separate disposal is thereby reduced.

If this new individual primary packaging is used in conjunction with secondary packaging incorporating a combined transportation and disposal system (the subject of the authors patent U.S. Pat. No. 6,283,909), a further reduction in volume for transportation, and syringe disposal volume will be realized.

BRIEF DESCRIPTION OF THE EXEMPLARY EMBODIMENTS

An exemplary but non-limiting embodiment described herein relates to applying shrink-wrap packaging material or film to individual syringes. This approach impacts and simplifies the sterilization, maintenance of internal sterility and transportation of medical devices, such as hypodermic syringes, prior to use. It allows the use of a syringe without significantly compromising the accuracy of the syringe. It also reduces the volume of waste disposal after use. The resultant benefits will be a reduction in some or all of: cost of production, sterilization, transportation and disposal of medical devices such as syringes and needles. Safe and effective packaging may be obtained with an expected reduction in weight of packaging of 50%, and in volume of packaging requiring disposal, significantly greater than 50%. Additionally, in some embodiments, the ability to use the syringe without the need to remove some or all of the packaging prior to use is enabled. This will result in reduced waste packaging requiring disposal after use with no appreciable increase in the volume of syringe waste requiring disposal. This is achieved as much of the packaging is retained closely or tightly applied to the syringe and is not removed from the syringe.

Medical syringe or other device packaging including individual closely applied such as shrink-wrapping, as described herein, may include the following features and/or advantages:

Effective individual coverage (primary packaging) of the syringe and needleguard (needlecap) to maintain internal and external sterility of the syringe after sterilization and before use.

Reduction in individual syringe/packaging volume over traditional systems, thereby reducing size and cost of secondary packaging, storage boxes and transportation cartons.

Reduction in individual syringe packaging and box and carton volume, thereby reducing sterilization time and cost.

Reduction in individual syringe packaging and box and carton volume, thereby reducing transportation costs and/or difficulties.

The ability to remove some or all of the individual syringe packaging prior to use (requiring external or internal sterility or both, e.g., in the operating room use or in vaccination programs).

Reduction in cost and environmental impact of disposal of packaging through reduced individual syringe/packaging volume, box and carton size.

Some packaging may remain on the syringe yet still allow unrestricted plunger motion and essentially full use of injection function of syringe. This can be accomplished with no significant increase in disposal volume or disposal cost of syringe.

Packaging allows visualization of index markings while still on the syringe, i.e., without need for complete removal.

Packaging will accommodate a variety of methods of removal, e.g., axial or transverse pull tabs, complete or partial removal, providing use-specific function.

The pull tabs described are incorporated with the shrink wrap film during factory manufacture. This process requires expensive equipment and cannot be easily replicated outside the manufacturing facility thereby effectively preventing deceptive repackaging of used syringes.

The use of specifically designed pull tabs or shrink wrap film with peculiarities including for example specific structural or color features will tend to thwart deceptive repackaging of used syringes.

Ability of packaging to allow other safety syringe related functions such as anti-needlestick needle retraction after use.

Optional syringe features simplify removal of individual primary packaging, e.g., features on needle cap tent the film wrap, allowing easier puncture and removal.

Improved resistance to accidental contamination of the syringe, e.g., water, mold or fungal destruction when compared to some traditional packages, e.g., Tyvek®.

Accordingly, in one aspect, the invention relates to a syringe package comprising a single syringe entirely enclosed and sealed within a shrink-wrap film or package.

In another aspect, the invention relates to a syringe package comprising a single syringe entirely enclosed and sealed within a shrink-wrap film or package, wherein the syringe includes a barrel, a plunger slidable within the barrel, a thumb press at one end of the plunger projecting rearwardly of the barrel, and a needle at an opposite end of the barrel, and wherein the shrink-wrap package is formed with at least one pull tab connected to an annular line of weakening located at a distal end of the syringe adjacent to the needleguard syringe junction and rearward of the needle tip.

In still another aspect, the invention relates to a syringe package comprising a single syringe entirely enclosed and sealed within a shrink-wrap package, wherein the syringe includes a barrel, a plunger slidable within the barrel, a thumb press at one end of the plunger projecting rearwardly of the barrel, and a needle at an opposite end of the barrel, at least one of the syringe and the shrink wrap package provided with means for facilitating removal of at least a portion of the shrink wrap package.

In still another embodiment, the invention relates to a method of packaging, using and disposing of a syringe comprising: enclosing and sealing a single syringe assembly within a shrink wrap package, the syringe assembly including a barrel, a plunger slidable within the barrel, a thumb press at one end of the plunger projecting rearwardly of the barrel, and a needle at an opposite end of the barrel; removing a portion of the shrink wrap package enclosing the needle; using the syringe in a liquid injection or removal mode while leaving a remaining portion of the shrink wrap package on the syringe assembly; and disposing the used syringe assembly with the remaining portion of the shrink wrap package in place on the syringe.

The embodiments noted above can be construed to be applicable to syringes whether empty or pre filled with medication or other medical devices wherein the internal sterility of the device is required; however the external surface need or cannot be maintained as sterile during or before use.

The invention will now be described in detail in connection with the drawing figures identified below and using a syringe as an example of a relevant medical device.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a side elevation of a syringe, individually packaged in accordance with an exemplary but non-limiting embodiment;

FIG. 2 is a side elevation of a syringe, individually wrapped in accordance with another exemplary embodiment; and

FIG. 3 is a side elevation of a syringe with yet another exemplary embodiment.

DETAILED DESCRIPTION OF THE INVENTION

With reference to FIG. 1, a packaged individual syringe assembly 10 includes a conventional syringe 12 having a syringe barrel 14, a plunger 16 slidable within the barrel, a thumb press 18 at the proximal end of the plunger and projecting rearwardly of the barrel, and a needle 20 at the distal end of the barrel. A shrink-wrap package 22 encloses and seals the syringe assembly, with closed ends at 24 and 26. The shrink wrap material may be conventional material typically used for shrink wrap applications or may have specific characteristics such as color radiation tolerance, gaseous permeability or non toxic products when disposed by incineration. The transparency of the material is significant here in that the index markings on the syringe barrel are easily visible when portions of the shrink wrap material remain on the syringe during use, as described further herein. Adjacent the proximate end of the syringe (adjacent the thumb press 18), an integral and extended finger hold or pull tab 28 enables the proximal portion of the shrink-wrap covering the thumb press to be disrupted and removed with possibly with the aid of a partial tear line 30. At the same time, a finger hold or pull tab 32 may be located at the opposite or distal end of the syringe, again with a partial tear line 34 extending from the pull tab, enabling the distal end of the shrink wrap to be removed. It will be appreciated that other techniques for facilitating tearing of the shrink wrap material may be employed. For example, reducing the thickness of the material along the desired tear pattern, will create a line of weakening that will function in a manner similar to a partial tear line.

By removing the two closed ends 24, 26 of the shrink-wrap package, followed by removal of the needle cap 36, the syringe 12 may be used with unrestricted plunger motion, and with full use of a liquid injection or removal function, while leaving a majority of the shrink-wrap material in place on the barrel of the syringe. The remaining portion of the shrink-wrap package may remain along the barrel, but could be removed if desired.

In the FIG. 2 embodiment, a finger hold or pull tab 138 projects axially from the distal end 126 of the shrink-wrap package 122. The pull tab may be connected to a partial tear line (or other line of weakening) 140 that extends axially substantially the length of the syringe barrel 114. With this arrangement, the entire shrink-wrap package 122, including the closed ends 124 and 126 may be removed from the syringe 112 simply by pulling the finger hold or pull tab 138 axially along the length of the syringe. Upon removal of the needle cap 136, the syringe is ready for use.

FIG. 3 illustrates yet another exemplary embodiment, similar to the embodiment in FIG. 2, but where the needle cap 236 is provided with a lateral extension, edge or flange 242 at its open end, engaged by the shrink-wrap cover 222 causing the shrink wrap film to be tented over the flange. The user may run his/her fingernail around the flange 242 of the needle cap 236, thereby severing the closed distal end portion 224 of the shrink-wrap package from the remainder of the package, permitting easy removal of the closed-end 224 of cover forward of the flange 242. This allows the film to be easily disrupted or rent adjacent this tented area. Starting at this disruption the edge of the shrink wrap film can be easily grasped and complete removal of the shrink wrap film or cover is simplified. In this example the axial tab is also included to simplify removal if desired as in the FIG. 2 embodiment. Removal of the proximal closed end portion 226 of the shrink wrap package can be achieved in a similar manner, with the user pressing about one of the edges presented by the fingerhold 244 at the proximal end of the syringe barrel 214, axially adjacent the thumb press 218. Thus, the embodiment in FIG. 3 permits the user to remove any or all of the distal end, proximal end and intermediate portions of the shrink wrap package. Note in this regard that the shrink-wrap cover may be formed with partial tear strips or otherwise weakened annular lines about the flange 242 and/or flange 244. In a variation of this arrangement, the shrink wrap package need not have any lines of weakening, insofar as the user may use the needle cap flange 242 and/or barrel flange 244 to facilitate removal of desired portions of the shrink wrap package as described above. In all cases, removal of some or all of the shrink wrap packaging effectively destroys the packaging, thereby acting as a temper evident control on repackaging with the original material.

It will be appreciated further that the syringes with applied shrink-wrap packaging may be utilized under conditions where both the interior and exterior of the syringe is required to be sterile (by removing the entire shrink-wrap cover) or where just the interior is required to be sterile (in which case, part of the shrink-wrap cover may be left in the syringe). In the situation where external sterility is also required, the shrink wrapped syringes can be placed in an additional closed tray as is often used for bulk sterilization of syringes to be used for example for allergy testing. In this case, the shrink wrapped syringes from this additional enclosed tray can be peeled and ejected onto a sterile field and used safely. These sterilization techniques are well understood by those of ordinary skill in the medical sterilization field. In all cases, storage, shipping and disposal volumes are significantly reduced with attendant decreases in cost.

While the invention has been described in connection with what is presently considered to be the most practical and preferred embodiment, it is to be understood that the invention is not to be limited to the disclosed embodiment, but on the contrary, is intended to cover various modifications and equivalent arrangements included within the spirit and scope of the appended claims. 

1. A syringe package comprising a single syringe entirely enclosed and sealed within a shrink-wrap film or package.
 2. The syringe package of claim 1 wherein said syringe includes a barrel, a plunger slidable within the barrel, a thumb press at one end of the plunger projecting rearwardly of the barrel, and a needle at an opposite end of the barrel.
 3. The syringe package of claim 1 wherein said shrink-wrap package is formed with at least one pull tab for removing at least a portion of said shrink-wrap package.
 4. The syringe package of claim 1 wherein said shrink-wrap package or pull tab is formed of materials of distinctive, easily recognized color or structure.
 5. The syringe package of claim 3 wherein said shrink-wrap package is formed with a pair of pull tabs at opposite ends of said package.
 6. The syringe package of claim 2 wherein said shrink-wrap package is formed with at least one pull tab for removing at least a portion of said shrink-wrap package, said pull tab connected to a partial tear or weakened strip extending axially along the barrel of the syringe.
 7. The syringe package of claim 3 wherein said pull tab is connected to a line of weakening extending annularly about the syringe at a distal end thereof, rearward of said needle.
 8. The syringe package of claim 3 wherein said pull tab is connected to a line of weakening extending annularly about the syringe at a proximal end thereof, forward of said thumb press.
 9. The syringe package of claim 2 wherein said syringe is also provided with a needle cap formed with a radially outwardly directed flange engaged by said shrink-wrap package.
 10. The syringe package of claim 2 wherein said barrel is formed with a flange of a proximate end thereof, adjacent said thumb press.
 11. A syringe package comprising a single syringe entirely enclosed and sealed within a shrink-wrap package, wherein said syringe includes a barrel, a plunger slidable within the barrel, a thumb press at one end of the plunger projecting rearwardly of the barrel, and a needle at an opposite end of the barrel, and wherein said shrink-wrap package is formed with at least one pull tab connected to an annular line of weakening located at a distal end of said syringe but rearward of said needle.
 12. A syringe package comprising a single syringe entirely enclosed and sealed within a shrink-wrap package, wherein said syringe includes a barrel, a plunger slidable within the barrel, a thumb press at one end of the plunger projecting rearwardly of the barrel, and a needle at an opposite end of the barrel, at least one of said syringe and said shrink wrap package provided with means for facilitating removal of at least a portion of said shrink wrap package.
 13. A tamper-evident syringe package comprising a single syringe entirely enclosed and sealed within a shrink-wrap package, wherein said syringe includes a barrel, a plunger slidable within the barrel, a thumb press at one end of the plunger projecting rearwardly of the barrel, and a needle at an opposite end of the barrel, at least one of said syringe and said shrink wrap package provided with means for facilitating removal and destruction of at least a portion of said shrink wrap package.
 14. A method of packaging, using and disposing of a syringe comprising: enclosing and sealing a single syringe assembly within a shrink wrap package, the syringe assembly including a barrel, a plunger slidable within the barrel, a thumb press at one end of the plunger projecting rearwardly of the barrel, and a needle at an opposite end of the barrel; removing a portion of the shrink wrap package enclosing the needle; removing a portion of the shrink wrap package enclosing the end of the plunger using the syringe in a liquid injection or removal mode while leaving a remaining portion of the shrink wrap package on the syringe assembly; and disposing the used syringe assembly with the remaining portion of the shrink wrap package in place on the syringe.
 15. The method of claim 14 including providing one of said syringe and said shrink wrap package with means for facilitating removal of at least a portion of said shrink wrap package.
 16. The method of claim 15 wherein said means may annularly or axially oriented. 